Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus (HPV) Vaccine With Other Vaccines in Healthy Female Subjects
A Multicentre Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' HPV Vaccine (580299) Co-administered With Boostrix Polio (dTpa-IPV) in Healthy Female Subjects Aged 10-18 Years
1 other identifier
interventional
751
3 countries
38
Brief Summary
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescents platform. Therefore, this Phase IIIb study is designed to evaluate the safety and immunogenicity of co-administering Boostrix polio (dTpa-IPV) with GSK Biologicals' (580299)HPV-16/18 L1 AS04 vaccine (Cervarix TM) as compared to the administration of either vaccine alone. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2007
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2007
CompletedFirst Posted
Study publicly available on registry
January 24, 2007
CompletedStudy Start
First participant enrolled
February 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2008
CompletedResults Posted
Study results publicly available
August 23, 2010
CompletedJuly 20, 2018
April 1, 2017
1.1 years
January 23, 2007
November 12, 2009
May 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Subjects Seroprotected Against Diphtheria and Tetanus
Seroprotection against diphtheria and tetanus is defined as anti-diphtheria and anti-tetanus antibody titres greater than or equal to 0.1 International Units per Milliliter (≥ 0.1 IU/mL).
One month after vaccination with Boostrix Polio
Titers of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin Toxoid (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies
Titers are given as geometric mean titers (GMTs) calculated on all subjects and expressed as Enzyme-linked Immunosorbent Assay Units per Milliliter (EL.U/mL).
One month after vaccination with Boostrix Polio
Number of Subjects Seroprotected Against Poliovirus Type 1 (Polio 1), Polio 2 and Polio 3
Seroprotection against polio 1, 2 and 3 is defined as anti-polio 1, 2 and 3 antibody titers greater than or equal to 8 Effective Dose 50% (≥ 8 ED50).
One month after vaccination with Boostrix Polio
Secondary Outcomes (12)
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-HPV-18 Antibodies After Completing the Cervarix Vaccination Course
One month post Cervarix Dose 3 (Month 7/8)
Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies After Incomplete Cervarix Vaccination Course
One month post Dose 1
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies After Completing the Cervarix Vaccination Course
One month post Cervarix Dose 3 (Month 7/8)]
Titers of Anti-diphtheria and Anti-tetanus Antibodies
One month after vaccination with Boostrix-Polio
Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Titers Above 1.0 International Units Per Milliliter (IU/mL)
One month after vaccination with Boostrix Polio
- +7 more secondary outcomes
Study Arms (3)
Cervarix Group
EXPERIMENTALSubjects who received GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM) at Month 0, 1 and 6.
Boostrix Polio → Cervarix Group
EXPERIMENTALSubjects who received Boostrix™ Polio at Month 0 and GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM) at Month 1, 2 and 7.
Cervarix + Boostrix Polio Group
EXPERIMENTALSubjects who received GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
Interventions
One dose of vaccine administered intramuscularly
Three doses of vaccine administered intramuscularly, with the second and third dose give one month and six months after the first dose respectively
Eligibility Criteria
You may qualify if:
- Subjects who the investigator believes that they and their parents/legally acceptable representatives can, and will, comply with the requirements of the protocol should be enrolled in the study.
- A female between, and including, 10 and 18 years of age at the time of the first vaccination.
- Written informed consent/assent obtained from the subject prior to enrolment. For subjects above the legal age of consent, written informed consent must be obtained from the subject. For subjects below legal age of consent, written informed consent obtained from the subject's parent/LAR, and written informed assent must be obtained from the subject.
- Healthy subjects, as established by medical history and history-directed physical examination, before entering into the study.
- Previously completed routine childhood vaccinations according to the recommended vaccination schedule at the time.
- Subjects must have a negative urine pregnancy test.
- Subject must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. Subjects who reach menarche during the study, and therefore become of childbearing potential, must agree to follow the same precautions.
You may not qualify if:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 12/13).
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after each dose of vaccine(s). Administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
- A woman planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.
- Pregnant or breastfeeding women.
- Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
- Previous administration of components of the investigational vaccine
- Administration of a diphtheria, tetanus, pertussis (DTP) vaccine, diphtheria-tetanus (Td) booster or dTpa vaccine within the previous five years.
- Administration of a pre-school booster of Oral Polio Vaccine (OPV) or Inactivated Polio Virus (IPV) vaccine (4 or 5th dose) within the previous five years.
- Hypersensitivity to latex.
- Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality or thrombocytopenia, as determined by previous physical examination or laboratory tests.
- Cancer or autoimmune disease under treatment.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- History of encephalopathy within seven days of administration of a previous dose of pertussis vaccine that is not attributable to another identifiable cause.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (38)
GSK Investigational Site
Auch, 32000, France
GSK Investigational Site
Draguignan, 83300, France
GSK Investigational Site
Essey-lès-Nancy, 54270, France
GSK Investigational Site
Évreux, 27000, France
GSK Investigational Site
Le Havre, 76600, France
GSK Investigational Site
Luynes, 37230, France
GSK Investigational Site
Montbrison, 42600, France
GSK Investigational Site
Nice, 06300, France
GSK Investigational Site
Paris, 75015, France
GSK Investigational Site
Paris, 75020, France
GSK Investigational Site
Pont-de-l'Arche, 27340, France
GSK Investigational Site
Rouen, 76100, France
GSK Investigational Site
Toulon, 83000, France
GSK Investigational Site
Tours, 37000, France
GSK Investigational Site
Vieux-Condé, 59690, France
GSK Investigational Site
Ettenheim, Baden-Wurttemberg, 77955, Germany
GSK Investigational Site
Karlsruhe, Baden-Wurttemberg, 76199, Germany
GSK Investigational Site
Kehl, Baden-Wurttemberg, 77694, Germany
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68167, Germany
GSK Investigational Site
Offenburg, Baden-Wurttemberg, 77654, Germany
GSK Investigational Site
Ravensburg, Baden-Wurttemberg, 88212, Germany
GSK Investigational Site
Rheinstetten, Baden-Wurttemberg, 76287, Germany
GSK Investigational Site
Munich, Bavaria, 80637, Germany
GSK Investigational Site
Würzburg, Bavaria, 97070, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60439, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30625, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30657, Germany
GSK Investigational Site
Wolfenbüttel, Lower Saxony, 38302, Germany
GSK Investigational Site
Leipzig, Saxony, 04109, Germany
GSK Investigational Site
Nordhausen, Thuringia, 99734, Germany
GSK Investigational Site
Berlin, 10315, Germany
GSK Investigational Site
Berlin, 13086, Germany
GSK Investigational Site
Hamburg, 20246, Germany
GSK Investigational Site
Hamburg, 22143, Germany
GSK Investigational Site
Hamburg, 22159, Germany
GSK Investigational Site
Madrid, 28046, Spain
GSK Investigational Site
Pamplona, 31008, Spain
GSK Investigational Site
Seville, 41013, Spain
Related Publications (3)
Schwarz T et al. Co-administration of AS04-adjuvanted HPV-16/18 cervical cancer vaccine with DTPA-IPV in 10-18 year old girls: Month 7 results from a randomized trial. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.
BACKGROUNDBergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.
PMID: 41276263DERIVEDGarcia-Sicilia J, Schwarz TF, Carmona A, Peters K, Malkin JE, Tran PM, Behre U, Iturbe EB, Catteau G, Thomas F, Dobbelaere K, Descamps D, Dubin G; HPV Vaccine Adolescent Study Investigators Network. Immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccine coadministered with combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine to girls and young women. J Adolesc Health. 2010 Feb;46(2):142-51. doi: 10.1016/j.jadohealth.2009.11.205.
PMID: 20113920DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2007
First Posted
January 24, 2007
Study Start
February 13, 2007
Primary Completion
March 17, 2008
Study Completion
July 25, 2008
Last Updated
July 20, 2018
Results First Posted
August 23, 2010
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.